ULTOMIRIS can lower the ability of your immune system to fight infections. Ultomiris is a formulation of ravulizumab produced in Chinese hamster ovary (CHO) cell culture by recombinant DNA technology. NDC 25682-022-01. Administer ULTOMIRIS only through a 0.2 or 0.22 micron filter. Table 15 presents the demographics and baseline characteristics of the 56 adult patients enrolled in Study ALXN1210-aHUS-311 that constituted the Full Analysis Set. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections. Copyright © 2021 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. Animal reproduction studies were conducted in mice using doses of a murine anti-C5 antibody that approximated 1-2.2 times (loading dose) and 0.8-1.8 times (maintenance dose) the recommended human ULTOMIRIS dose, based on a body weight comparison. ULTOMIRIS treatment of aHUS should be a minimum duration of 6 months. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving ULTOMIRIS have not been established. Renal function, as measured by eGFR, was improved or maintained during ULTOMIRIS therapy. WARNINGS AND PRECAUTIONS adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). ULTOMIRIS®(ul-toe-meer-is)(ravulizumab-cwvz) injection, for intravenous use. See. The safety and efficacy of ULTOMIRIS for the treatment of aHUS appear similar in pediatric and adult patients [see ADVERSE REACTIONS, and Clinical Studies]. As with all therapeutic proteins, there is potential for immunogenicity. Table 17 presents the baseline characteristics of the pediatric patients enrolled in Study ALXN1210-aHUS-312. See additional information. In clinical trials, 5 out of 296 patients treated with ULTOMIRIS experienced infusion-related reactions (lower back pain, drop in blood pressure, infusion-related pain, elevation in blood pressure and limbs discomfort) during ULTOMIRIS administration which did not require discontinuation. Advise patients that administration of ULTOMIRIS may result in infusion reactions. All responses were maintained through all available follow-up. The use of ULTOMIRIS increases a patient's susceptibility to serious meningococcal infections (septicemia and/or meningitis). Long-term animal carcinogenicity studies of ravulizumab-cwvz have not been conducted. Efficacy was established based on hemolysis as measured by LDH percent change from baseline to Day 183 and supportive efficacy data was transfusion avoidance, proportion of patients with stabilized hemoglobin, and the proportion of patients with breakthrough hemolysis through Day 183. Prescribers must counsel patients about the risk of meningococcal infection/sepsis, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccines. Ultomiris is a slightly bigger protein than Soliris and has a tweak that lets the body recycle and reuse it. Abbreviations: CI = confidence interval; LDH = lactate dehydrogenase; TMA = thrombotic microangiopathy. adults and children 1 month of age and older with a disease called, the treatment of adult patients with paroxysmal nocturnal, the treatment of adults and pediatric patients one month of age and older with atypical hemolytic uremic syndrome (aHUS) to, The number of vials to be diluted is determined based on the individual patient's weight and the prescribed dose [see. Connect with a live representative. ULTOMIRIS blocks terminal complement activation; therefore, patients may have increased susceptibility to encapsulated bacteria infections, especially infections caused by Neisseria meningitidis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent, Neisseria gonorrhoeae. At baseline, 35.7% (n = 5) of patients had a CKD Stage 5. Table 6: Adverse Reactions Reported in ≥10% of ULTOMIRIS-Treated Patients with aHUS in Study ALXN1210-aHUS-311. There are no specific data on ULTOMIRIS discontinuation. Ultomiris injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults. The mechanism of action for IVIG in MG is uncertain. Table 17: Demographics and Baseline Characteristics in Study ALXN1210-aHUS-312. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of ULTOMIRIS. Ravulizumab-cwvz consists of 2 identical 448 amino acid heavy chains and 2 identical 214 amino acid light chains and has a molecular weight of approximately 148 kDa. Ultomiris 300 mg/3 mL concentrate for solution for infusion Each vial of 3 mL contains 300 mg of ravulizumab (100 mg/mL). Due to heterogeneous nature of aHUS events and patient-specific risk factors, treatment duration beyond the initial 6 months should be individualized. Not indicated in STEC‑HUS.1, aThe mean (%CV) terminal elimination half-life and clearance of ULTOMIRIS in patients with atypical-HUS are 51.8 (31.3) days and 0.08 (53.3) L/day, respectively. It is a humanized monoclonal antibody that binds to the human C5 complement protein; thus, inhibiting terminal complement-mediated intravascular All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. ULTOMIRIS is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Each single-dose vial contains 300 mg ravulizumab-cwvz at a concentration of 10 mg/mL with a pH of 7.0. When animal exposure to the antibody occurred in the time period from before mating until early gestation, no decrease in fertility or reproductive performance was observed. ULTOMIRIS ® (ravulizumab-cwvz ... 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3feel faint or pass out Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 14.1 Paroxysmal Nocturnal Hemoglobinuria (PNH) Do not heat the admixture in a microwave or with any heat source other than ambient air temperature. After discontinuing treatment with ULTOMIRIS, patients should be monitored for clinical symptoms and laboratory signs of TMA complications for at least 12 months. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. %CV=coefficient of variation; FcRn=human neonatal Fc receptor; TMDD=target-mediated drug disposition. Provide 2 weeks of antibacterial drug prophylaxis to patients if ULTOMIRIS must be initiated immediately and vaccines are administered less than 2 weeks before starting ULTOMIRIS therapy. adults and children 1 month of age and older with a disease called atypical hemolytic uremic syndrome (aHUS). If an adverse reaction occurs during the administration of ULTOMIRIS, the infusion may be slowed or stopped at the discretion of the physician. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Seventeen of the 29 patients (59%) who required dialysis at study entry discontinued dialysis by the end of the available follow-up and 6 of 27 (22%) patients were off dialysis at baseline were on dialysis at last available follow-up. Your doctor will decide if you need additional meningococcal vaccination. Under the ULTOMIRIS REMS, prescribers must enroll in the program. Levosimendan, a small molecule that acts by increasing calcium sensitivity in both heart and skeletal muscle fibers, was originally developed by Orion to treat acute heart failure. Intravenous injections of male and female mice with a murine anti-C5 antibody at up to 0.8-2.2 times the equivalent of the clinical dose of ULTOMIRIS had no adverse effects on mating or fertility. Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Table 12: Efficacy Results in the Complement-Inhibitor Naïve Study. The mean total PNH granulocyte clone size was 85%, the mean total PNH monocyte clone size was 88%, and the mean total PNH RBC clone size was 39%. Protect from light. Complete TMA Response was achieved at a median time of 86 days (range: 7 to 169 days). are breastfeeding or plan to breastfeed. The heavy and light chain variable regions that form the human C5 binding site consist of human framework regions grafted to murine complementarity-determining regions. Counsel patients about gonorrhea prevention and advise regular testing for patients at risk. In order to qualify for enrollment, patients were required to have a platelet count ≤150 × 109/L, evidence of hemolysis such as an elevation in serum LDH, and serum creatinine level ≥97.5% percentile at screening or required dialysis. Mechanism of Action (MOA), Pharmacokinetics (PK), and Pharmacodynamics (PD) MOA: Ravulizumab-cwvz is a terminal complement inhibitor. Other endpoints included platelet count change from baseline, dialysis requirement, and renal function as evaluated by eGFR. Withdraw the calculated volume of ULTOMIRIS from the appropriate number of vials and dilute in an infusion bag using 0.9% Sodium Chloride Injection, USP to a final concentration of 5 mg/mL. Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risk of developing a meningococcal infection. Monitoring Disease Manifestations after ULTOMIRIS Discontinuation [see. The fourth patient, who was excluded from the trial after a diagnosis of STEC-HUS, died due to pretreatment cerebral arterial thrombosis. Inform patients about the signs and symptoms of meningococcal infection/sepsis, and strongly advise patients to seek immediate medical attention if these signs or symptoms occur. The recommended dosing regimen in adult patients with PNH weighing 40 kg or greater, consists of a loading dose followed by maintenance dosing, administered by intravenous infusion. The most frequent serious adverse reactions reported in more than 2 patients (2.7%) treated with ULTOMIRIS were hypertension, pneumonia and abdominal pain. The adult study [ALXN1210-aHUS-311; NCT02949128] was conducted in patients who were naïve to complement inhibitor treatment prior to study entry. Four of the 5 patients who required dialysis at study entry were able to discontinue dialysis after the first month in study and for the duration of ULTOMIRIS treatment. There was no observable difference in fatigue between ULTOMIRIS and eculizumab after 26 weeks of treatment compared to baseline as measured by the FACIT-fatigue instrument. Do not use if there is evidence of particulate matter or precipitation. Patients were vaccinated against meningococcal infection prior to or at the time of initiating treatment with ULTOMIRIS or eculizumab, or received prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination. Patients who demonstrated clinically stable disease after being treated with eculizumab for at least the prior 6 months were randomized 1:1 to either continue eculizumab or to switch to ULTOMIRIS. Table 11: Baseline Characteristics in the Complement-Inhibitor Naïve Study. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. The safety and effectiveness of ULTOMIRIS for the treatment of aHUS have been established in pediatric patients aged one month and older. The mean eGFR (+/- SD) increased from 28.4 (23.11) at baseline to 108.0 (63.21) by 26 weeks. Human IgG are known to cross the human placental barrier, and thus ULTOMIRIS may potentially cause terminal complement inhibition in the fetal circulation. Call your doctor right away if you have any new signs or symptoms of infection. ULTOMIRIS requires dilution to a final concentration of 5 mg/mL. Knowledge about drug, mechanism of action, and briefing of clinical evidences; Detailed information and insights on the drug Upadacitinib which is manufactured by AbbVie Inc. , Ultomiris (ravulizumab-cwvz) a humanized monoclonal antibody manufactured by Alexion Pharmaceuticals Inc. and many more What is the most important information I should know about ULTOMIRIS? Major baseline characteristics were balanced between treatment groups. Under the ULTOMIRIS REMS, prescribers must enroll in the program [see WARNINGS AND PRECAUTIONS]. Ultomiris is used to treat: It is not known if Ultomiris is safe and effective in children with PNH. Refer to the administration reference tables below. Complete TMA Response was observed in 10 of the 14 patients (71%) during the 26-week Initial Evaluation Period as shown in Table 18. Treatment should not alter anticoagulant management. Use aseptic technique to prepare ULTOMIRIS as follows: Only administer as an intravenous infusion. Ravulizumab-cwvz pharmacokinetics increase proportionally over a dose range of 200 to 5400 mg. Ravulizumab-cwvz Cmax and Ctrough parameters are presented in Table 9 and Table 10. Tables 6, 7 and 8 describes adverse reactions that occurred at a rate of 10% or more among patients treated with ULTOMIRIS in aHUS studies. The mean (%CV) terminal elimination half-life of ravulizumab-cwvz in patients with PNH and aHUS are 49.7 (18.0) days and 51.8 (31.3) days, respectively. The active substance contained in Ultomiris, ravulizumab, is a monoclonal antibody (a type of protein) designed to attach to the C5 protein, which is part of the complement system. Vaccinate patients for meningococcal disease according to current ACIP guidelines to reduce the risk of serious infection [see WARNINGS AND PRECAUTIONS]. Components of Complete TMA Response Platelet count normalization, ≥25% improvement in serum creatinine from baseline. Under the ULTOMIRIS REMS, prescribers must enroll in the program. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations. Effects of ravulizumab-cwvz upon fertility have not been studied in animals. Trade Name: Ultomiris® Ravulizumab is the generic name for the trade name drug Ultomiris. ... Due to its mechanism of action, the use of ravulizumab increases the patient's susceptibility to meningococcal infection/sepsis (Neisseria meningitidis). You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS. Enrollment in the ULTOMIRIS REMS program and additional information are available by telephone: 1-888-765-4747 or at www.ultomirisrems.com. - Knowledge about drug, mechanism of action, and briefing of clinical evidences - Detailed information and insights on the drug Upadacitinib which is manufactured by AbbVie Inc. , Ultomiris (ravulizumab-cwvz) a humanized monoclonal antibody manufactured by Alexion Pharmaceuticals Inc. and many more Table 8: Adverse Reactions Reported in ≥10% of ULTOMIRIS Treated Patients from Birth to 16 Years of Age with aHUS in Study ALXN1210-aHUS-312.
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